Senior R&D Engineer, Medical Devices (Onsite Irvine)

Talentburst,-Inc; Irvine (CA); On-site; USD 110,000 - 150,000; Full time

Job summary

Talentburst, Inc. is seeking a Senior R&D Engineer for an on-site Irvine, CA role. You will support lifecycle management of Class III medical devices, investigate field issues, and drive design and process improvements post‑commercial release.

The role emphasizes hands-on problem solving, data analysis, design control, and cross-functional collaboration with quality, manufacturing, and regulatory teams to ensure product safety and performance in a regulated setting.

Qualifications

• Bachelor's degree in Engineering or Scientific field with 4+ years of experience.
• Master's degree or equivalent in Engineering or Scientific field with 3+ years of experience.
• Ph.D. or equivalent in Engineering or Scientific field.

Responsibilities

• Lead investigations and resolve device field issues by analyzing product performance data, customer feedback, and failure reports.
• Define and execute engineering studies and testing to determine root cause and support effective actions.
• Collaborate with cross-functional teams to implement design changes and process improvements to enhance device reliability.
• Monitor device performance and quality metrics and address deviations.
• Lead design and process changes for on-market medical devices and manage change control processes.
• Lead risk management activities including updates to FMEAs, hazard analyses, and risk files.
• Develop, review, and execute engineering test plans, protocols, and reports to support changes and regulatory responses.
• Maintain comprehensive documentation of changes, investigations, and test records for regulatory compliance.
• Work with manufacturing, quality assurance, regulatory affairs, and suppliers to support lifecycle management.

Skills

Python

Minitab

Excel

CAD

Risk management

Design controls

Data analysis

Cross-functional collaboration

Documentation

Education

Bachelor's degree in Engineering or Scientific field

Master's degree or equivalent in Engineering or Scientific field

Ph.D. or equivalent in Engineering or Scientific field

Tools

Minitab

Solid CAD tools

Excel

Job description

Talentburst, Inc. is seeking a Senior R&D Engineer for an on-site Irvine, CA role. You will support lifecycle management of Class III medical devices, investigate field issues, and drive design and process improvements post‑commercial release.

The role emphasizes hands-on problem solving, data analysis, design control, and cross-functional collaboration with quality, manufacturing, and regulatory teams to ensure product safety and performance in a regulated setting.